Authority listing for terbinafine extended to children and adolescents

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The authority listing for terbinafine 250 mg tablets was extended on 1 March 2010. Any child or adolescent (< 18 years) may now receive treatment for a dermatophyte infection that has not responded to topical treatment and oral griseofulvin. Similarly, the streamlined authority listing for terbinafine 1% cream now includes the treatment of fungal or yeast infections in this age group.1 These authority listings were previously restricted to Aboriginal and Torres Strait Islander people only.2

The Pharmaceutical Benefits Advisory Committee recommended the extended listings on the basis of clinical need for children and adolescents.1 The TGA-approved product information does not recommend terbinafine tablets for children or adolescents, and the cream is not recommended for children < 12 years.3,4 However, there are some small trials to support use in children and adolescents5‑7 and paediatric oral dose recommendations are available (see Box 1).5,8 Terbinafine oral granules* are indicated for people > 4 years in the US (with slightly higher mg/kg dose recommendations).9

*Not available in Australia.

Box 1: Paediatric dose recommendations for terbinafine tablets*

Weight (kilogram)

Daily dose (mg)

< 20

62.5

20–40

125

> 40

250

* 250 mg scored tablets are the only strength available in Australia, so doses for children < 40 kg require tablets to be broken

Prescribe terbinafine tablets only if terbinafine cream and oral griseofulvin have not treated the fungal infection: if > 6 weeks of terbinafine tablets are required, monitor blood count and liver enzymes.10 Oral terbinafine is associated with rare but serious adverse effects (e.g. blood dyscrasias, liver failure).3,11–13 The US FDA found that skin reactions were the most often reported postmarketing adverse event for terbinafine for children.14

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Date published: 1 March 2010Reasonable care is taken to provide accurate information at the time of creation. This information is not intended as a substitute for medical advice and should not be exclusively relied on to manage or diagnose a medical condition. NPS MedicineWise disclaims all liability (including for negligence) for any loss, damage or injury resulting from reliance on or use of this information. Read our full disclaimer. This website uses cookies. Read our privacy policy.